Congressional report: States lax on compounding pharmacies

A new report released Monday by U.S. Rep. Ed Markey and four other U.S. congressmen found that compounding pharmacies do not face close scrutiny in most states, many of which barely keep track of the licensed facilities.

By Scott O'Connell/Daily News staff

The Herald News, Fall River, MA

By Scott O'Connell/Daily News staff

Posted Apr. 16, 2013 at 12:01 AM
Updated Apr 16, 2013 at 4:05 PM

By Scott O'Connell/Daily News staff

Posted Apr. 16, 2013 at 12:01 AM
Updated Apr 16, 2013 at 4:05 PM

» Social News

A new report released Monday by U.S. Rep. Ed Markey and four other U.S. congressmen found that compounding pharmacies do not face close scrutiny in most states, many of which barely keep track of the licensed facilities.

Compiled by staff in Markey's office over the past six months, the "State of Disarray" report also discovered that lax attitude has made policing the businesses difficult, with little information shared among states and the U.S. Food and Drug Administration.

“In states from coast to coast, compounding pharmacies are going untracked, unregulated, and under-inspected, exposing patients everywhere to tainted drugs, disease and death,” Markey said. “Even states with stronger compounding standards cannot effectively police the activities of pharmacies in 49 other states that sell drugs across state lines."

Markey has led a vocal campaign to reform the industry since a deadly meningitis outbreak was traced to the New England Compounding Center in Framingham last year.

The report, he said, supports his argument for more FDA involvement in regulation and oversight of compounding pharmacies. Eben Burnham-Snyder, a spokesman in Markey's office, said the congressman is revising his initial bill on the issue, the VALID Compounding Act, to reflect the new data from the report.

"(He's going to) try to make sure we have this compounding industry regulated once and for all," said Burnham-Snyder, who added Markey would reintroduce the updated bill soon.

But many of the compounding pharmacies that would be affected by Markey's measure don't agree greater federal control is the way to go.

"We believe that states, with the right regulations and proper enforcement, can serve as the most effective regulators of compounding pharmacies and can ensure that these pharmacies are providing quality, safe medications for those patients who depend on them," said David Ball, a spokesman for the International Academy of Compounding Pharmacies, a trade group that represents 2,700 members.

In a separate statement responding to Monday's report, Ball said state regulations and policy on compounding pharmacies have been changing "day by day" since the meninigitis outbreak, and that many of the concerns raised by Markey are being addressed. The academy has also released its own recommendations to improve the standards and practices of the states' boards of pharmacy, he added.

But Markey and the other lawmakers who announced the report on Monday - congressmen U.S. Reps. Henry Waxman, D-Calif., John Dingell, D-Mich., Frank Pallone, D-N.J., and Diana DeGette, D-Colo. - said its "shocking" findings require more intervention.

"For the past two decades, the Food and Drug Administration has operated under unclear authority and has been hamstrung in their efforts to work with states to ensure compounded drugs are safe for our citizens," DeGette said. "Congress must act to provide the clarity in the law that is so desperately needed, and it must do so before another tragedy occurs."

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Among the other findings:

- 37 states do not routinely track which pharmacies are providing sterile compounding services, like the kind that led to last year's meningitis outbreak;

- 22 states do not keep any historical pharmacy inspection records;

- And on average, states only employ five inspectors to look after all of their pharmacies.

Scott O'Connell can be reached at 508-626-4449 or soconnell@wickedlocal.com